Intermediate Selection Criteria in Pharmaceutical Synthesis Processes, identified by the CAS number provided and its IUPAC name and InChIKey, plays a critical role as an intermediate in modern pharmaceutical manufacturing. Its well-defined molecular formula and molecular weight support robust traceability throughout the synthesis pipeline, assuring that downstream processes maintain clarity regarding both chemical identity and purity.
Examining its physical and chemical attributes, this intermediate is specified through a number of reliable measures. Where available, values such as boiling point, melting point, density, flash point, and vapor pressure are carefully documented to inform both process optimization and safety protocols. Each property is vital not only to process chemists determining synthetic routes but also to those setting controls for safe handling and scale-up.
From a regulatory and compliance perspective, the status of this intermediate under authorities such as REACH, with its relevant article number and tonnage band, directly influences import, export, and site-specific registration decisions. Its TSCA inventory status, cited with the governing section, serves as a critical reference for US manufacturing and importers. ICH guidelines, including the precise code and revision as well as any specific impurity or exposure limits, anchor the product's alignment with international pharmaceutical expectations. Global chemical hazard declarations are included through the GHS framework, offering all harmonized hazard codes, precautionary H-phrases, and the signal word for effective communication across facilities and jurisdictions. References to any relevant pharmacopeia chapters further underline its suitability for regulated pharmaceutical applications, and if applicable, workplace exposure limits such as those issued by OSHA or NIOSH offer an additional layer of operational assurance.
The applications of Intermediate Selection Criteria in Pharmaceutical Synthesis Processes are rooted in its role as a synthesis intermediate. Its judicious use is documented in targeted drug manufacturing sequences, where it serves as a stepping stone for constructing complex active pharmaceutical ingredients or other advanced intermediates. It is not presented as a direct therapeutic agent but rather as a crucial enabler, connecting raw materials to the final drug substances through highly controlled and optimized steps.
When considering logistics and onsite management, this intermediate is typically supplied in standard packaging formats common to the pharmaceutical and fine chemical industries. These include 25-kilogram drums, 200-kilogram drums, and intermediate bulk containers (IBCs), allowing for flexible scale according to batch requirements. Storage recommendations are always tailored to the chemical's inherent stability and the specific requirements outlined by GHS safety data; for most non-volatile and stable intermediates, a cool, dry, and well-ventilated environment is indicated. Industry-standard shelf life guidance applies, generally ranging from two to five years depending on the stability of the particular compound and adherence to optimal storage practices.
For in-depth property and regulatory references, authoritative resources include the PubChem compound entry, the NIST Chemistry WebBook, the European Chemicals Agency record, and the EPA TSCA Inventory. These sources collectively offer a transparent and up-to-date basis for chemical procurement, compliance, and use in regulated pharmaceutical environments.
Sources:
PubChem: https://pubchem.ncbi.nlm.nih.gov/compound/{cid}
NIST: https://webbook.nist.gov/cgi/cbook.cgi?Name={cas_number}
ECHA: {echa_url}
EPA TSCA: https://www.epa.gov/tsca-inventory
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